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Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360073
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : November 14, 2012
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in patients with serious coronary heart disease using two UK primary care databases.

Condition or disease
Nonfatal Myocardial Infarction Coronary Death

Detailed Description:
Number of Anticipated Subjects: In case-control analysis: 10.000-15.000 participants

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Study Type : Observational
Actual Enrollment : 42542 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of Patients With Acute Serious Coronary Heart Disease
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Cases with nonfatal MI or coronary death
Age, sex, and calendar-year matched controls sampled from the original study cohort to be a round number of at least four times the number of cases

Primary Outcome Measures :
  1. Nonfatal MI or coronary death [ Time Frame: Up to eight years from entry into study cohort ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals aged 50-84 years who from 1 January 2000 to 31 December 2007 had a documented evidence of a hospitalization for a serious acute coronary event (MI, revascularization of coronary arteries or unstable angina) and who were alive 1 month after this event in two primary care clinical practice databases in the UK: General Practice Research Database (GPRD) and The Health Improvement Network (THIN).

Inclusion Criteria:

  • As above ( study population description).
  • All individuals aged 50-84 years with at least one year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.

Exclusion Criteria:

  • Recorded diagnosis of cancer prior to study start.
  • Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360073

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Research Site
Madrid, Spain
Research Site
Molndal, Sweden
Sponsors and Collaborators
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Principal Investigator: Luis A Garcia Rodriguez CEIFE (Centro Español de Investigación Farmacoepidemiológica)

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Responsible Party: AstraZeneca Identifier: NCT01360073    
Other Study ID Numbers: D961FN00007
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012
Keywords provided by AstraZeneca:
low dose aspirin
Nonfatal MI and coronary death
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors